SHANGHAI, April 9, 2024 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC2027. BC2027, which is BioCity's second first-in-class antibody drug conjugate (ADC) approved for clinical development, targets Glypican 3 (GPC3), a proteoglycan found in the outer membrane of cancer cells. BioCity's first ADC, BC3195, which is directed against another novel target called placental-cadherin (CDH3), a cell adhesion molecule that confers invasiveness and metastatic properties to cancer cells, is also in clinical trials.
WUXI, China, Feb. 25, 2024 /PRNewswire/ -- BioCity Biopharma is pleased to announce the completion of enrollment of all 120 participants in the IgA nephropathy (IgAN) cohort in a randomized, double-blind, placebo-controlled Phase 2 clinical study of the novel, oral endothelin A (ETA)-receptor selective antagonist SC0062, currently under development for chronic kidney disease (CKD), including IgAN and diabetic kidney disease (DKD). The enrollment of DKD cohort is ongoing with expected completion by the end of Q2 2024.
BioCity announces first patient dosed with anti-TIM-3 mAb BC3402 with IMFINZI
WUXI, China, Sept. 27, 2023 /PRNewswire/ -- September 25th, 2023, BioCity Biopharma and AstraZeneca signed an agreement to collaborate on a Phase Ib/II clinical study to evaluate the safety and efficacy of BioCity's BC3402, a monoclonal antibody (mAb) targeting the T cell immunoglobulin and mucin domain-containing protein 3, also known as TIM-3, in combination with AstraZeneca's anti-PD-L1 mAb IMFINZI (durvalumab) for the treatment of advanced hepatocellular carcinoma (HCC?in China. BioCity will lead the trial, which has received IND approval by the National Medical Products Administration (NMPA). The study will be conducted at Zhongshan Hospital with Prof. Jia Fan who is a renowned liver cancer surgeon, member of the Chinese Academy of Sciences, president of Zhongshan Hospital, and will serve as the principal investigator of the study.
WUXI, China, Aug. 7, 2023 /PRNewswire/ -- BioCity Biopharma today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Phase 1 study of BC3448 (CD3/EGFR Bispecific antibody, BsAb). As a result, BioCity Biopharma will initiate a dose escalation/expansion study with BC3448, enrolling patients with advanced solid tumors in the United States.
WUXI, China, July 19, 2023 /PRNewswire/ -- BioCity Biopharma, a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders, today announced the dosing of the first patient in a Phase 1a/1b clinical trial of its first-in-class CDH3 antibody drug conjugate (ADC), BC3195 in China. The study will assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BC3195 in patients with locally advanced or metastatic solid tumors.
WUXI, China, June 21, 2023 /PRNewswire/ -- BioCity Biopharma, a clinical-stage biopharmaceutical company committed to developing novel and highly differentiated, modality-independent therapeutics for cancer and autoimmune disorders, today announced the initiation of a randomized, placebo-controlled Phase 2 clinical trial of its novel, oral endothelin A (ETA)-receptor selective antagonist, SC0062, with the enrollment of two patients with IgA nephropathy?IgAN?in China?NCT05687890?. This multi-center study will assess the safety and preliminary efficacy of SC0062 relative to placebo in patients with chronic kidney disease with albuminuria.